Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

As pointed out above, the submission substance is not classified for the environment since it is inherently biodegradable in the aqueous environment, shows no acute or chronic toxicity to aquatic organisms and is not bioaccumulative or persistent.

The submission substance is not bioaccumulative (B) or very bioaccumulative (vB) based on calculated bioconcentration factor (BCF) or bioaccumulation factor (BAF) values. The low water solubility and high partition coefficient of the submission substance makes it very difficult to conduct an aqueous BCF study.  Data were mainly provided by the calculated bioconcentration factor (BCF) value of 0.893 and the calculated BAF value of 0.893 to 0.9475 for the submission substance using the U.S. Environmental Protection Agency EPI Suite model (v 4.00)(US EPA, 2009d). A further mitigating factor is the very high log Kow value (>10) which limits uptake across membranes due to bioavailability/membrane permeation constants. For the submission substance, the log Kow partition coefficient was determined experimentally by the HPLC method to be greater than 10 (Huntingdon Life Sciences, 2010a) while the calculated log Kow values of 10.03, 16.89 and 23.74 for the components were estimated using the EPI Suite model (U.S. EPA, 2009f).  

 

This data support the fact that the BCF value for the submission substance is well below 2000 L/kg which is the criterion for not being bioaccumulative (B) and is well below 5000 L/kg which is the criterion for not being very bioaccumulative (vB). The submission substance is inherently biodegradable and is not expected to be persistent (P) or very persistent (vP).

The submission substance also did not cause any acute or chronic aquatic toxicity at its maximum water solubility limit (not T).

Conclusion on classification

The environmental fate (Section 5) and aquatic toxicity (Section 6) data presented in IUCLID 5 support the conclusion that submission substance is not classified for the environment. No environmental classification or labelling is warranted. This is based on current findings which demonstrate that the submission substance is inherently biodegradable in the aqueous environment, shows no chronic or acute toxicity to aquatic organisms, and is not bioaccumulative or persistent, according to the criteria identified in 67/548/EEC.